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United States · US · US:68462-297_740c1d91-06c1-4508-9e94-e5308bec9be3

Ciclopirox Olamine

Orange BookUNIISPLATC D01AE

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeD01AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6846229717
    15 g in 1 CARTON (68462-297-17)
  • ndc11
    6846229735
    30 g in 1 CARTON (68462-297-35)
  • ndc11
    6846229792
    90 g in 1 CARTON (68462-297-92)

Annotations

UNII (FDA Substance ID)
50MD4SB4AP
CICLOPIROX OLAMINE
RxCUI 52172
Orange Book
A090273
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "50MD4SB4AP",
    "rxcui": "52172",
    "inchikey": "MBRHNTMUYWQHMR-UHFFFAOYSA-N",
    "display_name": "CICLOPIROX OLAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "1a74ed86-997a-4b86-b54a-b2b2c94e8abb": {
      "match": "brand_token",
      "title": "CICLOPIROX OLAMINE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]",
      "spl_version": "14",
      "published_date": "2026-04-17"
    }
  },
  "productid": "68462-297_740c1d91-06c1-4508-9e94-e5308bec9be3",
  "productndc": "68462-297",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "090273",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.77%",
        "product_no": "001",
        "approval_date": "Nov 10, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CICLOPIROX OLAMINE",
  "proprietary_name": "Ciclopirox Olamine",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA090273",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ciclopirox Olamine",
  "start_marketing_date": "20091113",
  "active_numerator_strength": "7.7"
}

Related drugs

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